Clinical trials: sponsored by Daiichi Sankyo
- Lead sponsor (exact) Daiichi Sankyo
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Hepatic Impairment
Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment
This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.
- Trial name
- NCT06740799
- Testing
- Quizartinib
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Healthy Subjects
Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin
Monotherapies for lowering LDL-C often do not achieve target lipid levels because they act on a single pathway, which may be insufficient in patients with high cardiovascular risk or complex lipid profiles.
- Trial name
- NCT07268625
- Testing
- Bempedoic acid, Ezetimibe, Atorvastatin
- Where
- Portugal
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Healthy Subjects
A Study Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Atorvastatin
Monotherapies for lowering LDL-C often do not achieve target lipid levels because they act on a single pathway, which may be insufficient in patients with high cardiovascular risk or complex lipid profiles.
- Trial name
- NCT07235189
- Testing
- Bempedoic acid, Ezetimibe, Atorvastatin
- Where
- Portugal
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Healthy Subjects
Evaluating Bioequivalence of a Fixed Dose Combination Versus Tablets of Bempedoic Acid / Ezetimibe and Rosuvastatin
The recommended first-line treatment of cardiovascular disease is a statin monotherapy; however, combination therapies represent an opportunity for an individualized, patient centered approach to low density lipoprotein…
- Trial name
- NCT07201545
- Testing
- Bempedoic acid, Ezetimibe, Rosuvastatin
- Where
- Portugal
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Healthy Subjects
Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Rosuvastatin
The recommended first-line treatment of cardiovascular disease is a statin monotherapy; however, combination therapies represent an opportunity for an individualized, patient centered approach to lower low density lipoprotein…
- Trial name
- NCT07182383
- Testing
- Bempedoic acid, Ezetimibe, Rosuvastatin
- Where
- Portugal
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Healthy Subjects
A Study to Evaluate QTc Prolongation With Quizartinib in Healthy Subjects Under Rapid Acceleration of Heart Rate
This study will evaluate the impact of rapid acceleration in the heart rate on the QT prolongation of quizartinib.
- Trial name
- NCT06772246
- Testing
- Quizartinib
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Healthy Subjects
Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects
This study will evaluate the effect of CYP3A weak inducer rufinamide on the pharmacokinetics (PK) of Quizartinib in healthy subjects
- Trial name
- NCT06740825
- Testing
- Quizartinib, Rufinamide
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Respiratory Syncytial Virus Infections
A Dose Finding Study of VN-0200
This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.
- Trial name
- NCT05547087
- Testing
- VN-0200
- Where
- 3 sites in Japan
- Volunteers
- 342 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Hepatic Impairment, Moderate Impaired Hepatic Function
A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment
Quizartinib is a novel oral Class III receptor tyrosine kinase (RTK) inhibitor exhibiting highly potent and selective but reversible inhibition of Feline McDonough sarcoma (FMS)-like tyrosine kinase 3 (FLT3).
- Trial name
- NCT04473664
- Testing
- Quizartinib
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Netherton Syndrome
A Study to Assess the Safety and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of DS-2325a in Healthy Subjects
Netherton syndrome (NS) is a rare autosomal recessive disease and no systemic treatment or standard of care currently exists for patients with NS.
- Trial name
- NCT05583669
- Testing
- DS-2325a
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Systemic Lupus Erythematosus
A Study of a Single Ascending Dose Study of DS-7011a in Healthy Subjects
This will be the first-in-human study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of DS-7011a in healthy participants.
- Trial name
- NCT05203692
- Testing
- DS-7011a
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Netherton Syndrome
A Study to Assess the Safety and Pharmacokinetics of Single Ascending Subcutaneous and Intravenous Doses of DS-2325a in Healthy Subjects
Netherton syndrome (NS) is a rare autosomal recessive disease and no systemic treatment or standard of care currently exists for patients with NS.
- Trial name
- NCT05388903
- Testing
- DS-2325a
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Healthy Subjects
A Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects
Quizartinib, a selective FLT3 inhibitor, is being developed as a treatment for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The absolute oral bioavailability of quizartinib has not yet been studied.
- Trial name
- NCT04796831
- Testing
- Quizartinib dihydrochloride, 14C-Quizartinib solution for infusion
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Pseudoxanthoma Elasticum
Pseudoxanthoma Elasticum (PXE) Natural History Biomarkers in PXE Individuals and Their Biological Non-PXE Siblings
This PXE biomarker study aims to characterize the levels of inorganic pyrophosphate (PPi), pyridoxal 5´-phosphate (PLP), and other biomarkers relevant to PXE and ectopic calcification in both PXE patients and their biological…
- Trial name
- NCT05025722
- Testing
- Non Interventional
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Covid19
Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects
This study will assess the safety, tolerability and immunogenicity of DS-5670a (COVID-19 Vaccine) and determine the recommended dose in Japanese healthy adults and elderly participants.
- Trial name
- NCT04821674
- Testing
- DS-5670a
- Where
- Japan
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo Co., Ltd.
Fibrodysplasia Ossificans Progressiva
Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects
This study will assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese participants.
- Trial name
- NCT04818398
- Testing
- DS-6016a
- Where
- Japan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo Co., Ltd.
Healthy Subjects, Drug-drug Interaction
A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants
This drug-drug interaction (DDI) study has been designed to investigate the effect of a moderate CYP3A inducer efavirenz on the pharmacokinetics of quizartinib and its major circulating active metabolite AC886.
- Conditions
- Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, Quizartinib
- Trial name
- NCT04459598
- Testing
- Efavirenz, Quizartinib
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo Co., Ltd.
Respiratory Syncytial Virus Infections
Study of VN-0200 in Japanese Healthy Adults and Elderly Subjects
This study will assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects.
- Trial name
- NCT04914520
- Testing
- VN-0200
- Where
- Japan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo Co., Ltd.
Healthy Subjects, Drug-drug Interaction
A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants
The purpose of this study is to investigate the one-way drug-drug interaction potential of quizartinib on dabigatran etexilate in healthy adult participants.
- Conditions
- Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, Quizartinib
- Trial name
- NCT04459585
- Testing
- Dabigatran Etexilate Mesylate, Quizartinib
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo Co., Ltd.
Atopic Dermatitis
Phase I Study of DS-2741a in Healthy Volunteers and Participants With Atopic Dermatitis
This is a phase 1, single-center, first-in-human study to assess the safety, pharmacokinetics and pharmacodynamics of DS-2741a after subcutaneous injection in healthy Japanese male volunteers and Japanese participants with…
- Trial name
- NCT04211415
- Testing
- DS-2741a
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo Co., Ltd.